NCT05366842

Patient-Reported Erectile Recovery and Quality of Life Outcomes With Lyopreserved Placental Tissue Applied Directly Over Neurovascular Bundle During Nerve Sparing Radical Prostatectomy Versus Standard of Care

Patient-Reported Erectile Recovery and Quality of Life Outcomes With Lyopreserved Placental Tissue Applied Directly Over Neurovascular Bundle During Nerve-Sparing Radical Prostatectomy Versus Standard of Care

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: Johns Hopkins University · Academic / Other
• Sex: Male
• Age: 40 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Surgical implantation of Lyopreserved Placental Tissue (LPT) is FDA approved and has been used extensively in wound care. The use is expanding and more recently, LPT has been used in the management of diabetic foot ulcers, acute and chronic surgical wounds, various fistulas and even as a nerve wrap on the common peroneal nerve. Surgical technique for nerve-sparing prostatectomy has evolved continuously since first described by Walsh in 1982 and is now commonly performed with robotic assistance. The investigators intend to study whether placement of LPT over the spared neurovascular bundle during nerve-sparing robotic prostatectomy will improve return to potency and/or continence after robotic radical prostatectomy for prostate cancer. Patients with a preoperative Sexual Health Inventory for Men (SHIM) score \> 19 (moderate or high pre-op sexual function) planning to undergo robotic-assisted laparoscopic prostatectomy will be randomized to receive direct placement of LPT over the preserved neurovascular bundles vs standard of care. Patients will independently report erectile function and continence at 1 months, 3 months, 6 months and 1 year after surgery. Primary outcomes would include mean time to achieve potency, percentage of group achieving potency at each time point, and mean change in SHIM score. Secondary outcomes would include mean time to achieve continence. The investigators will also report any adverse events.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DRUG	Stravix lyopreserved placental tissue (LPT)	Participants will undergo surgical implantation of Stravix lyopreserved placental tissue (LPT) during a standard of care radical prostatectomy.
PROCEDURE	Radical prostatectomy	Standard care (no placement of tissue)

Timeline

• Start date: 2022-04-01
• Primary completion: 2025-04-25
• Completion: 2025-04-25
• First posted: 2022-05-09
• Last updated: 2026-01-30
• Results posted: 2026-01-30

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study